[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LTK":3},{"classification":4,"mappedDevices":95,"similarCandidates":96,"relatedClassifications":170,"syncDates":231},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":88,"updated_at":89,"recall_count":90,"latest_recall_date":91,"k510_count":92,"pma_count":93,"event_count":94},4178,"LTK","Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)","2","866.6010","IM","Immunology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":85,"product_code":6,"review_panel":10,"gmp_exempt_flag":85,"third_party_flag":86,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":85,"medical_specialty_description":11,"summary_malfunction_reporting":87},{"k_number":17,"fei_number":44,"pma_number":75,"registration_number":77},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"K980240","K100321","K200199","K023597","K221355","K990431","K020828","K972162","K022329","K964098","K983875","K023891","K240479","K213510","K964185","K031297","K981297","K142895","K983715","K143534","K983391","K080561","K042731","K080469","K964020","K072794",[45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74],"1643621","1036362","3002808328","2122870","2967","3007019572","3005529799","3002809144","2432235","3004185580","3012963943","2521625","3011989923","3007111389","1219913","3002642396","3000308930","2250051","2020726","3005333358","3005622096","3005670738","3014643041","1000136573","2517506","3004192065","3002806944","3006198300","3002806559","3002895169",[76],"P850009",[45,46,48,78,51,52,53,79,80,55,56,57,58,59,81,82,83,60,61,62,63,64,84,65,67,69,70,71,72,74],"9612316","3005360469","9610126","8031673","1319681","8020888","2032839","N","Y","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-19T02:30:42.714273+00:00",8,"2018-05-16",26,6,227,[],[97,106,113,120,128,136,143,151,157,164],{"medical_device_id":98,"generic_name":99,"class_classification":100,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":105},1165,"体細胞遺伝子変異解析セット（抗悪性腫瘍薬適応判定用）","Ⅲ","71059023",0.114754,0,0.610922,0.0285312,{"medical_device_id":107,"generic_name":108,"class_classification":100,"jmdn_code":109,"name_similarity":110,"definition_similarity":103,"vector_similarity":111,"score":112},1140,"体細胞遺伝子変異解析システム（抗悪性腫瘍薬適応判定用）","71059003",0.112,0.629828,0.0284416,{"medical_device_id":114,"generic_name":115,"class_classification":100,"jmdn_code":116,"name_similarity":117,"definition_similarity":103,"vector_similarity":118,"score":119},1153,"体細胞遺伝子変異解析プログラム（抗悪性腫瘍薬適応判定用）","70159013",0.111111,0.616811,0.0277569,{"medical_device_id":121,"generic_name":122,"class_classification":123,"jmdn_code":124,"name_similarity":125,"definition_similarity":103,"vector_similarity":126,"score":127},2133,"卵巣内容液排出用セット","Ⅱ","70335000",0.157143,0.546891,0.0163934,{"medical_device_id":129,"generic_name":130,"class_classification":131,"jmdn_code":132,"name_similarity":133,"definition_similarity":103,"vector_similarity":134,"score":135},98,"ヘパリン使用心臓血管縫合補助具","Ⅳ","70290200",0.147727,0.468198,0.016129,{"medical_device_id":137,"generic_name":138,"class_classification":100,"jmdn_code":139,"name_similarity":140,"definition_similarity":103,"vector_similarity":141,"score":142},1078,"抗菌性カテーテル被覆・保護材","47937003",0.146667,0.437214,0.015873,{"medical_device_id":144,"generic_name":145,"class_classification":146,"jmdn_code":147,"name_similarity":148,"definition_similarity":103,"vector_similarity":149,"score":150},3450,"再使用可能な内視鏡用細胞診ブラシ","Ⅰ","38833000",0.0232558,0.610745,0.015625,{"medical_device_id":152,"generic_name":153,"class_classification":146,"jmdn_code":154,"name_similarity":155,"definition_similarity":103,"vector_similarity":156,"score":150},4449,"咀嚼能力検査用物質","71093001",0.141026,0.469102,{"medical_device_id":158,"generic_name":159,"class_classification":100,"jmdn_code":160,"name_similarity":161,"definition_similarity":103,"vector_similarity":162,"score":163},473,"硬膜外麻酔用カテーテル","35795000",0.138889,0.412027,0.0153846,{"medical_device_id":165,"generic_name":166,"class_classification":100,"jmdn_code":167,"name_similarity":168,"definition_similarity":103,"vector_similarity":169,"score":163},1139,"生殖細胞系列遺伝子変異解析プログラム（抗悪性腫瘍薬適応判定用）","71058003",0.104839,0.598201,[171,175,179,182,186,190,194,198,202,206,209,213,216,219,222,225,228],{"product_code":172,"device_name":173,"device_class":8,"k510_count":174},"LTJ","Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers",34,{"product_code":176,"device_name":177,"device_class":8,"k510_count":178},"DHX","System, Test, Carcinoembryonic Antigen",28,{"product_code":180,"device_name":181,"device_class":8,"k510_count":178},"MOI","System, Test, Immunological, Antigen, Tumor",{"product_code":183,"device_name":184,"device_class":8,"k510_count":185},"LOJ","Kit, Test,Alpha-Fetoprotein For Testicular Cancer",17,{"product_code":187,"device_name":188,"device_class":8,"k510_count":189},"MSW","System, Test, Thyroglobulin",13,{"product_code":191,"device_name":192,"device_class":8,"k510_count":193},"NIG","System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer",11,{"product_code":195,"device_name":196,"device_class":8,"k510_count":197},"MMW","System, Test, Tumor Marker, Monitoring, Bladder",9,{"product_code":199,"device_name":200,"device_class":8,"k510_count":201},"OIU","Test, Epithelial Ovarian Tumor Associated Antigen (He4)",5,{"product_code":203,"device_name":204,"device_class":8,"k510_count":205},"NCW","System, Test, Her-2\u002FNeu, Monitoring",3,{"product_code":207,"device_name":208,"device_class":8,"k510_count":205},"OVK","Cytokeratin Fragments 21-1 Eia Kit",{"product_code":210,"device_name":211,"device_class":8,"k510_count":212},"LOQ","Device, General Purpose, Hematology",1,{"product_code":214,"device_name":215,"device_class":8,"k510_count":212},"NTY","System, Test, Fibrin\u002FFibrinogen Degradation Products For Monitoring Of Colorectal Cancer",{"product_code":217,"device_name":218,"device_class":8,"k510_count":212},"OXP","Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment",{"product_code":220,"device_name":221,"device_class":8,"k510_count":212},"QTE","Thymidine Kinase Activity",{"product_code":223,"device_name":224,"device_class":8,"k510_count":212},"QXS","Chromogranin A",{"product_code":226,"device_name":227,"device_class":8,"k510_count":103},"MUT","Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer)",{"product_code":229,"device_name":230,"device_class":8,"k510_count":103},"NVA","Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma",{"510k":232,"classification":233,"enforcement":234,"event":235,"pma":236,"warning_letter":237},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]